Gardasil: More Adverse Reactions and Scandals

Despite Merck & Co.’s claims that
Gardasil is safe, stories abound over devastating
reactions to the three-shot inoculations that claim to
prevent some—not all—types of the human Papillomavirus
(HPV).

For instance, after just one injection a
13-year-old girl was diagnosed with Acute Pancreatitis,
spent nearly 100 days in the hospital, and underwent two
surgeries to remove Pseudocysts. Her family filed a
petition for vaccine compensation seeking damages from the
government.

A group of Australian researchers found young women there
who received the drug were five to 20 times likelier to
suffer rare and severe allergic reactions. In the U.S., a
20-year-old woman suffered a stroke after receiving a second
Gardasil injection. Two women overseas died after receiving
their Gardasil injections and those deaths followed the
deaths of three other young women who died in the U.S. days
after Gardasil was administered.

A 14-year-old girl experienced debilitating headaches,
fainting spells, and arthritis-like stiffness and became so
dizzy she could barely walk, was hospitalized, missed nearly
one month of school, and suffered a seizure. Another
13-year-old began showing signs of a degenerative muscle
disease after her third Gardasil injection; she is almost
completely paralyzed.

Now, the Rocky Mountain News is reporting about a
16-year-old girl who is sick all the time with constant
exhaustion and nausea; hair falling out in clumps, ongoing
episodes of passing out, numbness, and paralysis;
dangerously low blood pressure; and severe back spasms that
cause her to stop breathing. The family is convinced the
reactions are a result of Gardasil vaccinations, which in
her case, were given with a meningitis vaccine.

Although industry claims the Gardasil-meningitis
combination is safe, and although the combination is
routinely administered, Rocky Mountain News points out that
Gardasil has never been clinically tested in this
combination. As a matter-of-fact, the meningitis vaccine
was not available when clinical testing for Gardasil was
first being conducted, so the U.S.
Food and Drug Administration
(FDA) agreed to test it after licensure was granted said
Neal Halsey, director of the Institute for Vaccine Safety at
Johns Hopkins Bloomberg School of Public Health. Those
clinical results remain pending.

Worse, says Rocky Mountain News, according to the
National Vaccine Information Center, Gardasil reactions
increase when given with the meningitis vaccine. Also,
Halsey reported that general guidelines allow for two or
three inactivated vaccines—and Gardasil and the meningitis
vaccinations fall into this category—to be administered
conjunctively without an expectation of increased adverse
events.

Merck and Co.’s Gardasil was licensed in 2006 by the FDA
and both the Centers for Disease Control and Prevention
(CDC) and Merck say it is safe; however, as of late summer,
the federal Vaccine Adverse Event Reporting System (VAERS)
logged 10,326 reports of reactions to Gardasil, according to
the CDC, including reports of Guillain-Barre syndrome, a
rare disorder that causes muscle weakness, blood clots, and
death.

Gardasil accounted for about 20 percent of reactions
reported to VAERS in 2007-2008 according to Barbara Loe
Fisher, co- founder and president of the National Vaccine
Information Center. “To say that … 10,000 reports of
reactions, injuries, 30 deaths is all a coincidence is
simply not scientifically responsible,” Fisher told the
Rocky Mountain News. “You have perfectly healthy girls go in
and get this shot and then suffer a pattern, a very clear
pattern of injury, and some of them are dying. This is not
acceptable.” Side effects reported involve brain
inflammation; immune system dysfunction; tingling and
numbness in the hands, feet and legs; severe headaches;
strokes; joint pain; muscle weakness; seizures; and memory
loss Fisher said.

The Vue Weekly points out that many believe
over-immunization is a major contributor to the rise in
autoimmune disease and parents are often pressured to
immunize. But, in the case of Gardasil, perhaps avoiding
the vaccine might not be so irresponsible given that, as The
Vue pointed out, “the research was done by those who stand
to gain magnificently” and the drug has been the focus of
“an extensive public relations campaign” but “has been
subjected to little independent scientific review.”

Of note, the Vue points out that the Nobel Prize
Committee—which awarded the 2008 Nobel Prize in Medicine to
German scientist Harald zur Hauser for his work linking HPV
to cervical cancer—is facing investigation over bribery
allegations for taking payments from the drug company that
own the patents and collects royalties on both—U.S. and
overseas—HPV vaccines. Also, said the Vue, an FDA document
stated that, “identifying and typing HPV infection does not
bear a direct relationship to stratification of the risk for
cervical cancer. Most acute infections caused by HPV are
self-limiting. It is the persistent HPV infection that may
act as a tumor promoter in cancer induction … most
infections are short-lived and not associated with cervical
cancer.” Perhaps the vaccine is not so critical after-all.